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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89662

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
February 25, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Brainlab AG

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.

Z-0733-2022
Recall number
Z-0733-2022
Initiated
February 25, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Brainlab AG
Quantity
205 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.

Code information

Software versions 1.0.0, 1.0.1, 1.0.2, 1.0.3, GTIN 04056481142315.

Distribution pattern

Distribution was made to AZ, AR, CA, CO, FL, GA, IN, KY, MD, MS, MO, NJ, NY, NC, OK, OR, PA, TX, VA, and WA. There was no government or military distribution. Foreign distribution was made to Australia, Austria, Bahrain, Belgium, China, Denmark, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, New Zealand, Poland, Singapore, Slovakia, South Korea, Spain, Thailand, Turkey, United Kingdom, and United Arab Emirates.